FDA 483 - Pennsylvania State University IRB - April 26, 2017

An FDA inspection was conducted at Pennsylvania State University IRB, Office for Research Protections, from April 25-26, 2017, and resulted in a Form FDA 483 with two observations. The inspection identified issues with informed consent documents, essential for human subject research. The first observation noted that the informed consent document for a specific study did not disclose appropriate alternate procedures or courses of treatment that might benefit subjects. The second observation highlighted the absence of a statement in the informed consent documents informing subjects of the possibility that the Food and Drug Administration might inspect their records. These findings indicate areas of non-compliance with regulatory requirements for human subject protection and the informed consent process. While an FDA 483 lists observations and is not a final determination of compliance, it requires the firm to address these issues. Pennsylvania State University IRB is expected to implement corrective actions or discuss their response with the FDA to ensure their informed consent practices meet regulatory and ethical standards for research involving human subjects.